MX2019000031A - Procedimientos para la preparación de una solución de levotiroxina. - Google Patents

Procedimientos para la preparación de una solución de levotiroxina.

Info

Publication number
MX2019000031A
MX2019000031A MX2019000031A MX2019000031A MX2019000031A MX 2019000031 A MX2019000031 A MX 2019000031A MX 2019000031 A MX2019000031 A MX 2019000031A MX 2019000031 A MX2019000031 A MX 2019000031A MX 2019000031 A MX2019000031 A MX 2019000031A
Authority
MX
Mexico
Prior art keywords
levothyroxine
preparation
solution
methods
water
Prior art date
Application number
MX2019000031A
Other languages
English (en)
Inventor
Psarrakis Yannis
Lioumis Kosta
Original Assignee
Emp Pharmaceuticals B V
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Emp Pharmaceuticals B V filed Critical Emp Pharmaceuticals B V
Publication of MX2019000031A publication Critical patent/MX2019000031A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Se describe un procedimiento para la preparación de una composición de levotiroxina oral, que comprende las etapas de combinar levotiroxina o una sal de la misma, un disolvente orgánico miscible con agua o un alcohol de azúcar y agua, ajustar el pH a al menos 8 proporcionando un medio acuoso básico, disolver la levotiroxina en el medio acuoso básico para obtener una solución de levotiroxina y disminuir el pH de la solución de levotiroxina a entre 3,5-4,9. También se describe una composición de levotiroxina oral obtenible mediante dicho procedimiento y su uso como medicamento.
MX2019000031A 2016-07-05 2017-07-05 Procedimientos para la preparación de una solución de levotiroxina. MX2019000031A (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662358270P 2016-07-05 2016-07-05
NL2017110A NL2017110B1 (en) 2016-07-05 2016-07-05 Methods for the preparation of a levothyroxine solution
PCT/EP2017/066823 WO2018007466A1 (en) 2016-07-05 2017-07-05 Methods for the preparation of a levothyroxine solution

Publications (1)

Publication Number Publication Date
MX2019000031A true MX2019000031A (es) 2019-08-01

Family

ID=56936493

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019000031A MX2019000031A (es) 2016-07-05 2017-07-05 Procedimientos para la preparación de una solución de levotiroxina.

Country Status (7)

Country Link
US (2) US11096915B2 (es)
EP (1) EP3481426A1 (es)
JP (1) JP6664804B2 (es)
CA (1) CA3029569C (es)
MX (1) MX2019000031A (es)
NL (1) NL2017110B1 (es)
WO (1) WO2018007466A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL2017110B1 (en) * 2016-07-05 2018-01-12 Emp Levo Gmbh Methods for the preparation of a levothyroxine solution
KR20240036128A (ko) * 2017-06-02 2024-03-19 엑스에리스 파머수티클스, 인크. 침전 방지 저분자 약물 제제
KR20220024061A (ko) * 2019-05-31 2022-03-03 엑스에리스 파머수티클스, 인크. 비양성자성 극성 용매 중의 안정한 치료 조성물 및 이의 제조 방법
EP4061331A1 (en) 2019-11-22 2022-09-28 Wockhardt Limited Oral film composition comprising levothyroxine
CN116421557A (zh) * 2023-06-02 2023-07-14 泊诺(天津)创新医药研究有限公司 一种左甲状腺素钠口服液的制备方法
CN117919171B (zh) * 2024-03-22 2024-05-31 泊诺(天津)创新医药研究有限公司 一种左甲状腺素钠口服液的制备方法
CN120404996B (zh) * 2025-07-07 2025-09-23 湖北科林博伦新材料有限公司 一种甲苯氧化法生产苯甲醇工艺碱水中乙酸钠含量的分析方法

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1011118B (zh) 1986-06-13 1991-01-09 天津医学院附属医院 治疗白内障的眼药水的制药方法
GB9420705D0 (en) 1994-10-14 1994-11-30 Boots Co Plc Process
DE69633018T2 (de) * 1995-11-14 2004-12-09 Abbott Gmbh & Co. Kg Schilddrüsenhormone enthaltende stabilisierte arzneimittel und verfahren
IT1302201B1 (it) 1998-09-11 2000-07-31 Bracco Spa Processo per la produzione di ormoni tiroidei.
US20030199588A1 (en) * 2001-02-15 2003-10-23 Franz G. Andrew Levothyroxine compositions and methods
ITMI20011401A1 (it) * 2001-07-02 2003-01-02 Altergon Sa Formulazioni farmaceutiche per ormoni tiroidei
US20030195253A1 (en) * 2001-08-14 2003-10-16 Franz G. Andrew Unadsorbed levothyroxine pharmaceutical compositions, methods of making and methods of administration
JP2003255338A (ja) 2002-02-28 2003-09-10 Mitsubishi Electric Corp 液晶表示装置
CA2634993A1 (en) * 2006-01-06 2007-07-12 Intervet International B.V. Concentrated liquid thyroid hormone composition
WO2008014232A2 (en) 2006-07-24 2008-01-31 Emisphere Technologies, Inc. Pharmaceutical formulations for the treatment of alzheimer's disease
EP2274167A1 (en) 2008-05-06 2011-01-19 Lenzi Egisto S.p.A. Protective textile material against the action of melted materials
WO2009136249A1 (en) * 2008-05-09 2009-11-12 Cadila Pharmaceuticals Ltd. An improved process for the preparation of levothyroxine sodium with reduced levels of impurities
PL2683361T5 (pl) * 2011-03-10 2024-09-09 Helm Swiss Gmbh Sposób wytwarzania roztworu lewotyroksyny
GR1008017B (el) * 2012-08-03 2013-10-24 Verisfield (Uk) Ltd, Υποκαταστημα Ελλαδας, Εμπορια Φαρμακων, Σταθερο φαρμακευτικο συστημα (κιτ) για την παρασκευη ποσιμου διαλυματος λεβοθυροξινης ή φαρμακευτικως αποδεκτου αλατος αυτης
UA115247C2 (uk) * 2012-08-20 2017-10-10 Мерк Патент Гмбх Твердий фармацевтичний препарат, який містить левотироксин
US8779000B1 (en) * 2013-07-20 2014-07-15 Nilesh Parikh Saccharide free, storage stable thyroid hormone active drug formulations and methods for their production
WO2015151013A1 (en) * 2014-03-31 2015-10-08 Lupin Limited A process for preparation of levothyroxine and salts thereof
US9345772B1 (en) * 2015-02-27 2016-05-24 Nilesh Parikh Liquid levothyroxine formulations
NL2017110B1 (en) * 2016-07-05 2018-01-12 Emp Levo Gmbh Methods for the preparation of a levothyroxine solution

Also Published As

Publication number Publication date
EP3481426A1 (en) 2019-05-15
JP2019521185A (ja) 2019-07-25
US11096915B2 (en) 2021-08-24
US20190321316A1 (en) 2019-10-24
US20210353577A1 (en) 2021-11-18
WO2018007466A1 (en) 2018-01-11
US11938109B2 (en) 2024-03-26
NL2017110B1 (en) 2018-01-12
JP6664804B2 (ja) 2020-03-13
CA3029569C (en) 2020-08-11
CA3029569A1 (en) 2018-01-11

Similar Documents

Publication Publication Date Title
MX2019000031A (es) Procedimientos para la preparación de una solución de levotiroxina.
WO2017070616A3 (en) Sexually transmitted disease vaccines
MX2020005956A (es) Sales organicas de acido sulfonico de esteres de aminoacidos y proceso para su preparacion.
WO2016122887A8 (en) Oligosaccharide compositions for use as animal feed and methods of producing thereof
WO2017015433A3 (en) Compound targeting il-23a and b-cell activating factor (baff) and uses thereof
WO2013100176A3 (en) Method of producing a low odor glycerin derivative-modified silicone or a composition comprising the same
MY186547A (en) 4?-fluoro-2?-methyl substituted nucleoside derivatives
UA113962C2 (xx) Фармацевтична композиція, яка містить апоморфін як активний інгредієнт
AU2016237099B2 (en) Method for producing novel nitrogen-containing compound or salt thereof, and production intermediate of same
EP4674280A3 (en) Palatability enhancers for pet food, method of preparation and uses thereof
EP4327880A3 (en) Solid state form of ribociclib succinate
PH12016501175A1 (en) Formulations of deoxycholic acid and salts thereof
HK1217295A1 (zh) 4'-疊氮基，3'-脫氧基-3'-氟取代的核苷衍生物
MX2018005028A (es) Composicion para el cuidado de la piel y metodos para la misma.
AR074545A1 (es) Proceso de preparacion de dihidroetorfina
CA2922375C (en) Alpha-tea salt forms: compositions and uses for treating disease
JOP20240234A1 (ar) تخليق مشتقات إستر بورونات واستخداماتها
FI3331516T3 (fi) Ropivakaiinihydrokloridin hyperbaarinen liuosinjektio ja menetelmä sen valmistamiseksi
MX2019001691A (es) Composiciones que comprenden biopolímeros y métodos para su elaboración.
PH12016500913A1 (en) Soap bar
BR112018013408A2 (pt) derivados de c-glicosídeo que têm anel fenila fusionado ou sais farmaceuticamente aceitáveis dos mesmos, método para preparar os mesmos e composição farmacêutica compreendendo os mesmos
PH12014502844B1 (en) Method for producing concentrated aqueous solution of organic compound
WO2012015255A3 (en) Novel montelukast 4-halobenzylamine salt and method for preparing montelukast sodium salt by using the same
MX2018016115A (es) Composicion para el cuidado de la piel y uso de la misma.
WO2016022700A3 (en) Tlr-independent small molecule adjuvants